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Serum antibody titers GMTs were assessed in the per-protocol population.

Arm/Group Title

Influenza Virus Vaccine Formulation 1

Influenza Virus Vaccine Formulation 2

Fluzone® Elderly Group

Fluzone® High Dose Group

Fluzone® Adults Group

Arm/Group Description:

Participants aged 65 years or older...

Participants aged 65 years or older...

Participants aged 65 years or older...

Participants aged 65 years or older...

Participants aged 18 to 49 years wh...

Arm/Group Description:

Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System

Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System

Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)

Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)

Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)

Overall Number of Participants Analyzed

607

608

304

309

179

Geometric Mean (95% Confidence Interval)

Unit of Measure: Titers

A/H1N1 Pre Dose (N=604, 607, 304, 309, 179)

18.3

(16.9 to 19.8)

18.6

(17.1 to 20.2)

17.8

(15.7 to 20.0)

17.3

(15.3 to 19.5)

41.4

(32.6 to 52.7)

A/H1N1 Post Dose (N=605, 607, 304, 309, 179)

165.4

(149.2 to 183.4)

174.1

(157.5 to 192.4)

107.6

(93.2 to 124.3)

236.1

(207.3 to 268.9)

345.8

(294.1 to 406.6)

A/H3N2 Pre Dose (N=606, 608, 304, 309, 179)

103.8

(93.1 to 115.9)

104.7

(93.9 to 116.7)

95.1

(82.1 to 110.3)

99.3

(84.6 to 116.7)

73.0

(58.7 to 90.8)

A/H3N2 Post Dose (N=605, 608, 304, 309, 179)

348.3

(320.2 to 378.9)

378.4

(346.9 to 412.7)

276.9

(245.8 to 311.8)

508.0

(452.6 to 570.1)

398.3

(343.4 to 461.9)

B Pre Dose (N=607, 608, 304, 309, 179)

24.7

(22.9 to 26.6)

25.1

(23.3 to 27.1)

24.7

(22.2 to 27.4)

24.1

(21.7 to 26.8)

15.5

(13.4 to 17.9)

B Post Dose (N=607, 608, 304, 309, 179)

45.3

(42.3 to 48.4)

47.5

(44.3 to 50.9)

43.4

(39.2 to 48.0)

59.9

(54.5 to 65.9)

71.2

(61.7 to 82.3)

2.Primary Outcome

Title

Percentage of Participants Who Achieved Seroconversion Post-Vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine

Description

Seroconversion defined as either a pre-vaccination hemagglutination in...

Description

Seroconversion defined as either a pre-vaccination hemagglutination inhibition (HAI) titer < 1:10 and a post vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum four fold increase at one month post-vaccination.

Time Frame

Day 28 post-vaccination

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Serum antibody titers were assessed in the per protocol population.

Arm/Group Title

Influenza Virus Vaccine Formulation 1

Influenza Virus Vaccine Formulation 2

Fluzone® Elderly Group

Fluzone® High Dose Group

Fluzone® Adults Group

Arm/Group Description:

Participants aged 65 years or older...

Participants aged 65 years or older...

Participants aged 65 years or older...

Participants aged 65 years or older...

Participants aged 18 to 49 years wh...

Arm/Group Description:

Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System

Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System

Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)

Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)

Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)

Overall Number of Participants Analyzed

607

608

304

309

179

Measure Type: Number

Unit of Measure: Percentage of Participants

A/H1N1 (N=604, 607, 304, 309, 179)

73

74

61

82

62

A/H3N2 (N=605, 608, 304, 309, 179)

42

42

37

56

52

B (N=607, 608, 304, 309, 179)

15

15

9

26

44

3.Primary Outcome

Title

Percentage of Participants Who Achieved Seroprotection Before and Post-vaccination With Fluzone Intradermal or Fluzone High Dose or Fluzone Intramuscular Vaccine.

Description

Seroprotection was defined as a Hemagglutination inhibition (HAI) tite...

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.